Home » ISO 13485 Quality Manual and Procedures

ISO 13485 and FDA QSR (21CFR-820) Compliant QMS Upgrade Kit

If you have already implemented ISO 13485 and are ready to upgrade your system to be FDA compliant, this package will provide the additional documentation you will require.

NOTE: It is assumed that you have in place a COMPLETE ISO 13485 QMS! If not, you may need to purchase Additional Procedures

All you have to do it edit and customize each element to suit your own organization and needs. The Quality Manual and Procedures package is ideally suited for organizations and consultants in search of a proven, simple pathway to successful Registration.

Compare ISO 13485 and FDA QSR (21CFR-820)

All documents are written in MS Word or format for ease of editing.

• Document numbering system already created for solid Document Control
  
  
  
• View list of included procedures and forms

Contents:

Here's what you get in the ISO 13485 to ISO 13485 to FDA QSR (21CFR-820) Quality Manual and Procedure Upgrade Package:

Upgrade Instructions

5 Quality System Procedures designed to be the foundation of your customized quality management system.

• Please review ISO 13485 Documentation Requirements to understand what you need.
  
  
• View ISO 13485 procedure sample

6 related forms

• View ISO 13485 Form sample

Profit from the years of work that have gone into creating and refining this package. The key to an effective Quality Management System is designing the Quality Management Processes for efficiency and ease of use. The processes must be carefully thought out, well-organized, and carefully designed to work together to lead your organization to continuous improvement.

Our ISO professionals have done the hard part for you. Our system is the result of continual improvement of processes and procedures that have been tried, proven and improved over the last decade. They have lead thousands of companies across the globe to successful ISO Registration, and more importantly to internal improvements including productivity and profits.

Every purchase is backed by our guarantee, and comes with full customer support. If for any reason, you are not satisfied with our products, let us know within 15 days and you will receive a full and total refund. In addition, if you ever have any questions or comments, you can call us toll-free at 1-(877) 942-6572.

Order your copy of the Quality Manual and Procedures package TODAY.